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The Tracker / March 2026 / K252295

510(k) cleared

Ryurei

Terumo Corporation · Mar 27, 2026 · K252295

FDA cleared the Ryurei from Terumo Corporation on Mar 27, 2026 under K252295, a traditional 510(k). The device falls under product code LOX, Catheters, Transluminal Coronary Angioplasty, Percutaneous, regulated at 21 CFR 870.5100 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 23, 2025. The decision came 247 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Terumo Corporation has one other decision in the tracker over the last 12 months: K250700 (Pen Injector Needle 32.5).

Questions & Answers

What did FDA clear under K252295?

K252295 is the FDA 510(k) for Ryurei, submitted by Terumo Corporation. FDA's decision date was Mar 27, 2026, under product code LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous).

Who makes the Ryurei?

Terumo Corporation, based in Tokyo, is the applicant of record for K252295.

How long did the K252295 review take?

FDA received the submission on Jul 23, 2025 and issued its decision on Mar 27, 2026, 247 days later.

← All decisions in March 2026

Sources